Alembic Pharma gets USFDA nod for Phytonadione Injectable Emulsion ANDA

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, marketed by International Medication Systems.

Phytonadione Injectable Emulsion is used to treat hypoprothrombinaemia caused by vitamin K deficiency or interference. It is also indicated for the prophylaxis and treatment of vitamin K deficiency bleeding in neonates. For detailed indications, refer to the product label.

According to IQVIA, the estimated market size for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringes, is approximately US$44 million for the twelve months ending June 2025.

 

Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally.

The company's consolidated net profit jumped 14.6% to Rs 154.38 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024.

Shares of Alembic Pharmaceuticals shed 0.35% to Rs 943.95 on the BSE.

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